MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) INSTRUMENT PREPSTAIN TECAN US II REFURB; PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED

Catalog Number	490407
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Initial reporter phone #: (b)(6).H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using instrument prepstain tecan us ii refurb, the lid was falling and won't stay open.No patient impact reported.The following information was provided by the initial reporter: "tripath us ii - centrifuge two strut failure.The agent engineer, is in a hurry to give feedback.The centrifuge's support rod failed, but did not lose its support completely.There was no free fall, but a slow fall without injury.".
Additional Manufacturer Narrative
H.6.Investigation summary: complaint reports lid failure on centrifuge associated with prepmate (catalog number 490407) serial number (b)(6).Complaint alleges centrifuge lid gas springs failure, no support for the lid to stay open.Customer advised no one was hurt or injured.Customer replaced the centrifuge and post intervention the centrifuge was operating normally.Root cause attributed to faulty lid gas springs.This complaint is a confirmed failure of the instrument based on the customer investigation.Dhr review is not required because the part that allegedly failed is not tested as part of the manufacturing process but is shipped separately and tested during installation.Review of risk management files confirms there are no new or modified risks associated with this failure mode.There are no corrective action plans or other corrections occurring.Bd quality will continue to monitor for trends associated with failure of "centrifuge.".
Event or Problem Description
It was reported that while using instrument pepstatin tecan us ii refurb, the lid was falling and won't stay open.No patient impact reported.The following information was provided by the initial reporter: "tripath us ii - centrifuge two strut failure the agent engineer, is in a hurry to give feedback.The centrifuge's support rod failed, but did not lose its support completely.There was no free fall, but a slow fall without injury.".

• Brand Name: INSTRUMENT PREPSTAIN TECAN US II REFURB
• Common Device Name: PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED
• Manufacturer (Section D): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17606959
• Report Number: 1119779-2023-00924
• Device Sequence Number: 12328080
• Product Code: MKQ
• UDI-Device Identifier: 00382904904074
• UDI-Public: 00382904904074
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 490407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown